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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K161499
Device Name VertiForm Posterior Fixation System
Applicant
Next Orthosurgical
3270 Corporate View, Suite A
Vista,  CA  92081
Applicant Contact ELLEN YARNALL
Correspondent
Next Orthosurgical
3270 Corporate View, Suite A
Vista,  CA  92081
Correspondent Contact ELLEN YARNALL
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MKB   MNH   MNI   OSH  
Date Received06/01/2016
Decision Date 07/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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